What progress has China's biomedical industry made in July?

One minute Express A kind of Baiji Shenzhou and new base biology reach a global strategic cooperation A kind of Clinical trials of cornerstone pharmaceutical, Yasheng pharmaceutical and Wanchun pharmaceutical were approved by CFDA A kind of Zhongyu new drug AIDS breakthrough therapy has obtained the priority evaluation qualification 1 Xinji company and Baiji Shenzhou have reached a global strategic cooperation Xinji company and Baiji Shenzhou Co., Ltd have announced a strategic cooperation to jointly develop and promote the anti programmed cell death protein (PD-1) inhibitor bgb-a317 for the treatment of solid tumors The new base organism has obtained the exclusive license of bgb-a317 in the field of solid tumor, in Japan, as well as outside Asia Baekje reserves the right to develop in other regions of Asia except Japan Meanwhile, Baiji Shenzhou still has the global development right of bgb-a317 for the treatment of hematological malignancies In addition, Baiji Shenzhou will take over the operation of Xinji company in China and have the exclusive authorization of Xinji company's approved products in China, including atraxane ® paclitaxel for injection (albumin binding type), refumex ® (lenalidomide) and vidaza ® azacytidine for injection 2 Yasheng pharmaceutical, a leading original drug R & D enterprise in China, announced today that the anti-tumor new drug apg-115, which is independently designed and developed by the enterprise and has global intellectual property rights and acts on the new target MDM2-p53, has been approved by the State Food and Drug Administration (CFDA) to enter China's clinical practice This is another significant progress made by apg-115 after it was approved by FDA in June 2016 It is particularly noteworthy that it is the first MDM2-p53 inhibitor to enter clinical practice in China and will fill the gap in the field of drug development of this target in China 3 Cornerstone Pharmaceutical Co., Ltd obtained CFDA clinical trial approval for PD-L1 monoclonal antibody Cornerstone Pharmaceutical Co., Ltd announced on July 17 that the company's recombinant anti-PD-L1 all human monoclonal antibody injection cs1001 obtained the clinical trial approval issued by the State Food and Drug Administration (CFDA), marking China's The first natural full-length, all human anti-PD-L1 monoclonal antibody successfully entered the stage of clinical research and development At present, cornerstone pharmaceutical has launched a phase I clinical trial of cs1001 in patients with advanced cancer The proposed clinical indications include a number of common and high incidence cancers in China 4 In the treatment of bladder cancer, Baiji Shenzhou launched the key study of PD-1 monoclonal antibody Baiji Shenzhou announced that a key clinical trial of the PD-1 antibody bgb-a317 for Chinese patients with locally progressive or metastatic urothelial cancer (commonly referred to as bladder cancer) has been started, which has been incorporated into the first group of patients This clinical trial will be used to evaluate the efficacy of bgb-a317 in Chinese patients with treated, PD-L1 positive, locally progressive or metastatic bladder cancer Professor Ye Dingwei of Fudan University Cancer Hospital is the main researcher of this clinical trial 5 The clinical application of panabrin of Wanchun medicine was approved by CFDA On July 6, 2017, Wanchun medicine announced that the State Food and Drug Administration (CFDA) approved two 2 / 3-phase registered clinical trial applications (Project No 105 and 106) of its main drug panabrin for the prevention of neutropenia caused by chemotherapy Wanchun medicine is a biopharmaceutical company dedicated to the development of new tumor immunotherapy Professor Shi Yuankai, vice president of Cancer Hospital of Chinese Academy of Medical Sciences and a famous expert in the field of Chinese Shengbai medicine research, is the main researcher of the clinical trial 6 The breakthrough AIDS treatment of Zhongyu new drug has obtained the priority evaluation qualification Recently, taimed biology announced that the FDA of the United States has accepted the BLA of the breakthrough AIDS drug ibalizumab for the treatment of MDR HIV-1 This also means that the new drug is a step closer to patients The FDA's target approval date for the new drug (PDUFA) is January 3, 2018 If approved, ibalizumab will become the first antiretroviral treatment (Art) with new mechanism of action in nearly 10 years, and also the first treatment without daily medication.